A multicenter, randomized, open-label, controlled trial to evaluate the efficacy and tolerability of hydroxychloroquine and a retrospective study in adult patients with mild to moderate coronavirus disease 2019 (COVID-19)

被引：42

作者：

Chen, Cheng-Pin ^{[1
,2
]}

Lin, Yi-Chun ^{[1
,3
]}

Chen, Tsung-Chia ^{[4
]}

Tseng, Ting-Yu ^{[4
]}

Wong, Hon-Lai ^{[5
]}

Kuo, Cheng-Yu ^{[6
]}

Lin, Wu-Pu ^{[7
]}

Huang, Sz-Rung ^{[8
]}

Wang, Wei-Yao ^{[9
]}

Liao, Jia-Hung ^{[10
]}

Liao, Chung-Shin ^{[11
]}

Hung, Yuan-Pin ^{[12
]}

Lin, Tse-Hung ^{[13
]}

Chang, Tz-Yan ^{[13
]}

Hsiao, Chin-Fu ^{[14
]}

Huang, Yi-Wen ^{[13
,15
]}

Chung, Wei-Sheng ^{[4
,16
,17
]}

Cheng, Chien-Yu ^{[1
,18
]}

Cheng, Shu-Hsing ^{[1
,19
]}

机构：

[1] Minist Hlth & Welf, Taoyuan Gen Hosp, Dept Infect Dis, Taoyuan, Taiwan

[2] Natl Yang Ming Univ, Inst Clin Med, Taipei, Taiwan

[3] Taipei Med Univ, Grad Inst Clin Med, Taipei, Taiwan

[4] Minist Hlth & Welf, Taichung Hosp, Dept Internal Med, Taichung, Taiwan

[5] Minist Hlth & Welf, Keelung Hosp, Dept Internal Med, Keelung, Taiwan

[6] Minist Hlth & Welf, Pingtung Hosp, Dept Internal Med, Pingtung, Taiwan

[7] Minist Hlth & Welf, Taipei Hosp, Dept Internal Med, New Taipei, Taiwan

[8] Minist Hlth & Welf, Miaoli Gen Hosp, Dept Internal Med, Miaoli, Taiwan

[9] Minist Hlth & Welf, Feng Yuan Hosp, Dept Internal Med, Taichung, Taiwan

[10] Minist Hlth & Welf, Nantou Hosp, Dept Internal Med, Nantou, Taiwan

[11] Minist Hlth & Welf, Chia Yi Hosp, Dept Internal Med, Chiayi, Taiwan

[12] Minist Hlth & Welf, Tainan Hosp, Dept Internal Med, Tainan, Taiwan

[13] Minist Hlth & Welf, Chang Hua Hosp, Dept Internal Med, Changhua, Taiwan

[14] Natl Hlth Res Inst, Inst Populat Hlth Sci, Zhunan, Taiwan

[15] Chung Shan Med Univ, Inst Med, Taichung, Taiwan

[16] China Med Univ, Dept Hlth Serv Adm, Taichung, Taiwan

[17] Cent Taiwan Univ Sci & Technol, Dept Healthcare Adm, Taichung, Taiwan

[18] Natl Yang Ming Univ, Sch Publ Hlth, Taipei, Taiwan

[19] Taipei Med Univ, Sch Publ Hlth, Taipei, Taiwan

来源：

PLOS ONE | 2020年 / 15卷 / 12期

关键词：

CHLOROQUINE;

D O I：

10.1371/journal.pone.0242763

中图分类号：

O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

Objective In this study, we evaluated the efficacy of hydroxychloroquine (HCQ) against coronavirus disease 2019 (COVID-19) via a randomized controlled trial (RCT) and a retrospective study. Methods Subjects admitted to 11 designated public hospitals in Taiwan between April 1 and May 31, 2020, with COVID-19 diagnosis confirmed by pharyngeal real-time RT-PCR for SARS-CoV-2, were randomized at a 2:1 ratio and stratified by mild or moderate illness. HCQ (400 mg twice for 1 d or HCQ 200 mg twice daily for 6 days) was administered. Both the study and control group received standard of care (SOC). Pharyngeal swabs and sputum were collected every other day. The proportion and time to negative viral PCR were assessed on day 14. In the retrospective study, medical records were reviewed for patients admitted before March 31, 2020. Results There were 33 and 37 cases in the RCT and retrospective study, respectively. In the RCT, the median times to negative rRT-PCR from randomization to hospital day 14 were 5 days (95% CI; 1, 9 days) and 10 days (95% CI; 2, 12 days) for the HCQ and SOC groups, respectively (p = 0.40). On day 14, 81.0% (17/21) and 75.0% (9/12) of the subjects in the HCQ and SOC groups, respectively, had undetected virus (p = 0.36). In the retrospective study, 12 (42.9%) in the HCQ group and 5 (55.6%) in the control group had negative rRT-PCR results on hospital day 14 (p = 0.70). Conclusions Neither study demonstrated that HCQ shortened viral shedding in mild to moderate COVID-19 subjects.

引用

页数：14